FDA Registration Active 🇮🇹 Italy

MILLABLE POST, REP., INTERNAL

Reg #: 3001082453 · FEI: 3001082453 · Expires 2025
Products
2
Proprietary Names
297
Establishment Types
1
Classifications
2

Registration Details

Registration Name
SWEDEN & MARTINA S.P.A.
Registration Number
3001082453
FEI Number
3001082453
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Via Veneto, 10
City
Due Carrare Padova
Country
IT

Regulatory Submissions

510(k) Number
K142242

Owner / Operator

Firm Name
SWEDEN & MARTINA S.p.A.
Operator Number
10046682
Address
Via Veneto, 10
City
Due Carrare
State
Padova
Postal Code
35020
Country
IT

US Agent

Business Name
THEMA CORP
Contact Name
Silvia Tamarri
Address
2929 Arch Street
City
Philadelphia
State
PA
ZIP
19104
Country
US
Phone
215 8459459

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE

Proprietary Names

MILLABLE POST, REP., INTERNAL INSERT POSITIONER ANGLE MEASUREMENT GUIDE ROUND TIP OSTEOTOME D.20 NON REP. CAST.SLEEVE FOR ABUT. RETENTIVE TOP FOR POLYAMIDE CAP BALL ATTACHMENTS RETENT.LONG R.A. EASY INSERT THOMAS SPANNER KEY FOR SCREW REPOSITIONABLE ABUTMENT FOR RIGHT ANGLE SCREWDRIVER FOR SIMPLE TEMP. POST PEEK+TIT REP ANALOGUE FOR PAD ABUTMENT TRANSFER SCREW M1.8 H20 MM SPARE PLASTIC RING EXTRA SHORT SURGICAL HAND POST SCREW M2 STOP FOR CONICAL DRILL LOCATOR FEMALE ANALOG (D.4 MM) EXTENSION FOR HAND SCREWDRIVER TRANSFER SCREW M2 H10 MM RETENTION INSERT G RED MILLABLE REP. POST FOR LOCATOR ABUTMENT DRIVER (GOLD SPARE CAST. SLEEVE FOR GOLD PLAIN ABUTMENT H3 MM 4-IMPLANT KIT SURGICAL COVER SCREW P.A.D. ABUTMENT SCREW M2 SPARE SOFT RETENTION SPRING 17GR ANGLED PAD ABUT., H5 MM ABUTMENT PLAIN SCREWS M2 CASTABLE CENTERING DEVICE FOR TRANSFER SCREW M2 FOR LOCATOR ABUTMENT PRE/KOH TG CASTABLE REP. POST WITH GOLD LOCATOR REPLACEMENT MALE, PRE-MADE REP. POST STRAIGHT OPEN TRAY TRANSFER CARRIER FOR ANGLED ABUTMENT TRANSFER SCREW M14 FOR P.A.D. SURGICAL COVER SCREW PRE/KOH LOCATOR MALE PROCESSING PACK. LOCATOR PARALLEL POST (4 PCS) PULL-UP TRANSFER FOR PRE-KOH POST SCREW M1.8 FINAL CYLINDRICAL DRILL SFI-BAR IMPLANT ADAPTER ANALOGUE,SOLID ONE-PIECE ABUT. MOUNTER STOP KEY RETENT.EASY INSERT HAND DRIVER SILICONE SUPPORT FOR SCREWKIT TIT. SLEEVE FOR PAD ABUTMENT MILLABLE POST, REP., EXTERNAL PILOT DRILL SPARE CAST. SLEEVE FOR SHELTA IMPLANT ZIRTI REGULAR CLOSED TRAY TRANSF.FOR PREMIUM POM CAP FOR IMPRESSION TAKING PEEK CAST.SLEEVE FOR PAD ABUT. FEMALE PART T COMPLETE L47.5 SHORT PROSTHETIC HAND OPEN TRAY TRANSF.FOR RIP.ABUT. LOCATOR IMPRESSION COPING 20GR ANGLE PRE-MADE POST, REP. SMALL BALL JOINT S SOLID ONE-PIECE ABUTMENT SPARE CASTABLE SLEEVE FOR GOLD NON REP. TIT.SLEEVE FOR ABUT. MILLABLE POST, REP. SIMPLE TEMP.POST TIT. INTERNAL CASTABLE REP. POST WITH CRCO ANALOGUE FOR IMPLANT SHELTA IMPLANT ZIRTI WIDE POST SCREW M1.4 CAST. NON REP. POST WITH CR-CO EXTRA LONG PROSTHETIC HAND ANALOGUE FOR ABUTMENT SPARE RETENTION SPRING TIT.CAP TRANSFER JIG L26 FOR P.A.D. ABUTMENT SCREWS M1.8 TRANSGINGIVAL HEALING CAP H3MM TRANSFER SCREW M1.8 H10 MM SCREWDRIVER FOR IMPLANTAT ROUND TIP OSTEOTOME D.90 OPEN TRAY TRANSFER FOR PREMIUM HEALING CAP FOR ABUTMENT CASTABLE BAR ROUND PROFILE CAST.REP. POST WITH TITANIUM GOLD CAP D 2.20 MM RITENTION JACKET (4PS) FOR THE NON RETENT. LONG HAND DRIVER LOCATOR EXTEND.RANGE RETENTION STRAIGHT PAD ABUTMENT, H3 MM LOCATOR ABUTMENT PRE/KOH 50 CONCAVE TIP OSTEOTOME D.1.60 SILICONE SUPPORT FOR SURGICAL RUBBER O-RING 3,50x0,90 FOR ABUTMENT SCREW M2 OPEN TRAY TRANSFER SCREW M2 TITANIUM SLEEVE FOR PAD ABUT. SOLID ONE-PIECE ABUTMENT, H4MM IMPRESSION TAKING CAP FOR FEMALE PART ASYMMETRICAL 3 L30 ANALOGUE FOR IMPLANT D.3,80 MM LOCATORE CORE TOOL FOR LOCATOR PRE/KOH BONE PROFILER EXTENSION FOR SURGICAL DRILLS CONCAVE TIP OSTEOTOME D.20 RETENTION INSERT G YELLOW FINAL CONICAL DRILL SHELTA PREMIUM SP IMPLANT ZIRTI TITANIUM SLEEVE FOR NON REP. 2-IMPLANT KIT TRANSGINGIVAL HEALING CAP H7MM PULL-UP TRANSFER FOR NON RETENT. SHORT HAND DRIVER ANALOGUE FOR PLAIN ABUTMENT TWEEZERS LOCATOR MALE REMOVAL (TIP END) SHELTA IMPLANT ZIRTI WIDE PREMIUM BONE PROFILER RETENT.SHORT R.A. EASY INSERT SCREW M2 FOR RIP.ABUTMENT MOUNTER WITH SCREW FOR PRE/KOH REP. STRAIGHT ABUTMENT, H2 MM PIN DIVISIBLE FOR OVOIDAL BAR TUBE BAR S L20 TRANSGINGIVAL HEALING CAP H4,3 CASTABLE SLEEVE FOR PLAIN TORQUE CONTROLLED RATCHET KIT TITANIUM CAP FOR STANDARD BALL FEMALE PART HOUSING T L47.5 CAST. SLEEVE FOR 20GR ANGLED OPEN TRAY TRANSFER FOR ABUT. PULL-UP TRANSFER FOR PREMIUM LONG PROSTHETIC HAND SIMPLE TEMP. POST TIT. REP. TRANSGINGIVAL HEALING CAP H2MM T-CONNECT FOR SINGLE STRAIGHT PAD ABUTMENT, H4 MM RIGHT ANGLE BONE TAP HAND DRIVER FOR ABUTMENT PREMIUM DISC NO 1 TRANSGINGIVAL HEALING CAP H2,8 OPEN TRAY TRANSFER SCREW M1.8 30GR ANGLED PAD ABUT., H3 MM OPEN TRAY TRANSFER FOR PRE-KOH LOCATOR LIGHT RETENTION MALE, 15GR ANGLE PRE-MADE POST, REP. PARALLEL PIN FIXATION SCREW S HAND BONE TAP FOR SHELTA OPEN TRAY TRANSF.FOR PRE-KOHTG GAUGE AID HEALING CAP FOR PLAIN ABUTMENT CAST. NON REP. POST WITH GOLD TUBE BAR GAUGE TRANSGINGIVAL HEALING CAP BOPT HALF SHELL BALL S LOCATOR WHITE BLOCK-OUT SPACER TRANSFER SCREW M2 H15 MM HAND DRIVER FOR REP. ABUTMENT INTERMEDIATE DRILL 25GR ANGLE PRE-MADE POST, REP. PMMA CAST.SLEEVE FOR PAD ABUT. STRAIGHT PAD ABUTMENT, H1.5 MM SIMPLE TEMP.POST PEEK EXTERNAL T CONNECT FOR IMPLANT P.A.D. ABUTMENT SCREW M1.8 DEPTH GAUGE HOLE IMPLANTS LARGE BALL JOINT S GOLDEN BOX FOR O-RINGS TRANSGINGIVAL HEALING CAP H5MM CASTABLE CAP FOR PREMADE POSTS COMPLETE PACKAGING FOR SIMPLE TEMP. POST TIT. NON REP REP. CASTABLE SLEEVE FOR ABUT. LOCATOR ABUTMENT PRE/KOH 3,30 HAND BONE TAP FOR PRE/KOH POST SCREW M 2 PRE-MADE REP. POST ANATOMICAL BALL ATTACHMENT IMPL. PRE/KOH IMPLANT PLANNER ADD-ON KIT NON REP. ABUTMENT FOR HEX KEY FOR FIXATION SCREW CASTABLE BAR, OVOIDAL PROFILE HAND BONE TAP FOR PREMIUM HAND SCREWDRIVER FOR BALL CYLINDRICAL PILOT DRILL DESACTIVATOR MACRO FOR FEMALE OPEN TRAY TRANSF.FOR PAD ABUT. LOCATOR LIGHT RETENTION EXTEND HAND BONE TAP FOR KOHNO GOLD PINS U PROFILE FOR ROUND POST SCREWS M1.8 ANALOGUE FOR BALL ATTACHMENT CONCAVE TIP OSTEOTOME D.2.40 ABUTMENT PLAIN SCREW M2 TRANSGINGIVAL HEALING CAP H1,3 POST BOPT TECHNIQUE, PLAIN ABUTMENT H2 MM TRANSFER SCREW M1.8 H15 MM PLAIN ABUTMENT H4 MM ABUTMENT SCREW M1.8 COUNTERSINK DRILL D.4.10 MM POST SCREW M 1.8 FINAL CILINDRICAL DRILL LOCATOR BLACK PROCESSING SURGICAL COVER SCREW SHELTA STOP FOR CYLINDRICAL DRILL PRECISION DRILL OPEN TRAY TRANSF.FOR NON RIP. TRANSFER SCREW M2 H20 MM POST SCREWS M 2 SIMPLE TEMP.POST TIT. EXTERNAL HAND KNOB FOR DRIVERS, BONE CAST. NON REP. POST WITH CRCO REP. TITANIUM SLEEVE FOR ABUT. WHITE O-RING BALL ATTACHMENTS LONG SCREW DRIVER FOR LOCATOR REP. STRAIGHT ABUTMENT, H1 MM SHORT SURGIC. HAND SCREWDRIVER HEALING CAP FOR PRE-MADE POSTS PREMIUM IMPLANT ZIRTI TG TRANSGINGIVAL HEALING CAP H2.8 PROSTHETIC SCREW M1.4 FOR INSTRUMENT SET ANALOGUE FOR PRE-KOH TG ABUT. POST SCREWS M2 LONG SURGIC. HAND SCREWDRIVER STOP FOR SHORT DRILL PRE-ANGLED REP. MILLABLE POST POST SCREWS M 1.8 LOCATOR ABUTMENT PRE/KOH 4,25 RED O-RING BALL ATTACHMENTS HEALING PEEK CAP. WITH NARROW SHORT SCREW DRIVER FOR LOCATOR 17GR ANGLED PAD ABUT., H3 MM TEMP. CAP FOR PRE-MADE POSTS 30GR ANGLED PAD ABUT., H5 MM P.A.D. ABUTMENT SCREWS M2 STEEL CAP CONTAINER FOR BALL TRANSGINGIVAL HEALING CAP H1.3 LOCATOR ABUTMENT PRE/KOH 3,80 HEALING CAP FOR O-RING KIT FOR INSTRUMENTS RIGHT ANGLE CONNECTOR SOLID ONE-PIECE ABUTMENT, H7MM SURGICAL COVER SCREW PREMIUM SCREW FOR ABUTMENT TRANSFER HAND DRIVER FOR R.A. INSTRUM. ACTIVATOR SET FOR FEMALE PARTS LOCATOR EXTRA LIGHT RETENTION BALL ATTACHMENT IMPL. PRE-KOH STEEL CAP (2 PCS) SHORT HAND BONE TAP X-RAY TEMPLATES BLACK O-RING BALL ATTACHMENTS PREMIUM STRAIGHT IMPLANT ZIRTI SCREW M1.8 FOR RIP.ABUTMENT SPACER T CONNECT FOR IMPLANTS CLOSED TRAY TRANSF.FOR PRE-KOH RETENTION INSERT G GREEN SNAP ON CAP FOR CLOSED TRAY POST SCREWS M1.4 HAND DRIVER FOR TITANIUM CAP HAND PAD TRANSFER SCREW BOX FOR PRE-MADE POSTS HAND TRANSFER SCREW T-CONNECT FOR IMPLANTS BRIDGES T-CONNECT FOR SINGLE CROWN CAST. SLEEVE FOR SING. T-CONN. P_SLIM IMPLANT ZIRTI OPEN TRAY TRANSF.FOR RED. PAD PEEK SLEEVE FOR RED. PAD ANALOGUE FOR RED. PAD KOHNO ONE IMPLANT ZIRTI RED. PAD ABUTMENT SCREW SNAP ON CAP FOR IMPRESSION HAND RED. PAD TRANSFER SCREW 30GR ANG. RED. PAD ABUT. CAST. SLEEVE FOR MULT. T-CONN. TITANIUM SLEEVE 17GR ANG. RED. PAD ABUT. TIT. SLEEVE FOR RED. PAD STRAIGHT RED. PAD ABUT. PMMA CAST.SLEEVE FOR RED. PAD KOHNO STRAIGHT IMPLANT ZT IMPLANT ZIRTI PRE-MADE STRAIGHT ABUT. FOR ABUTMENT SCREW STRAIGHT EST. PAD ABUT. 17GR ANG. EST. PAD ABUT. 30GR ANG. EST. PAD ABUT.

Establishment Types

Manufacture Medical Device